The Clinical Application of Adipose-Derived Stem Cells on Facial Rejuvenation (ADSCs)

October 2, 2016 updated by: Jin Peisheng, Xuzhou Medical University
The purpose of this study is to determine whether the adipose-derived stem cells therapy is effective in the treatment of facial rejuvenation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will be a prospective study of patients who undergo adipose-derived stem cells therapy for facial rejuvenation at the hospital of Xuzhou medical university. The therapy involves injection of patient's own adipose-derived stem cells, which are separated from vacuumed fat obtained through liposuction of abdomen, hip, thigh and so on. It was confirmed the adipose-derived stem cells can be induced differentiation into fat cells, osteoblasts, chondrocytes, muscle cells, endothelial cells and so on under the corresponding condition in the current literature. The therapy has evolved as a less invasive technique for facial rejuvenation compared to more traditional techniques，such as fat cells injection, sodium hyaluronate injection. Through the use of pre and post treatment photos, three-dimensional skin CT, in addition to the therapeutic evaluation, patient satisfaction questionnaire and a clinician assessment, it is our hope that the investigators will confirm the rejuvenating capabilities of adipose-derived stem cells therapy.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females
  • Ages18-60
  • Patients of all racial and ethnic origins
  • Patients of all undergoing facial rejuvenation

Exclusion Criteria:

  • Ages under 18, and above 60
  • Female patients in pregnancy or menstrual period
  • Patients undergoing facial rejuvenation using other methods including botox injections, chemical peels, face lifts and others
  • Patients using blood thinners, aspirin and hormone, that cannot be stopped
  • Patients suffering with severe organic disease, such as coronary heart disease, hypertension, diabetes, lung dysfunction and so on
  • Patients suffering with mental disease, and acute or chronic infectious diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stem cells separation
Stem cells separation: The adipose-derived stem cells are separated from vacuumed fat obtained through liposuction of abdomen, hip, thigh and so on. It was confirmed the adipose-derived stem cells can be induced differentiation into fat cells under the special condition in the current literature.Stem cells are used to treat wrinkles and facial rejuvenation.
Biological: Adipose-derived stem cells
The adipose-derived stem cells therapy involve injection of patient's own adipose-derived stem cells. Local anesthetic will be applied to the face prior to the injection. For adipose-derived stem cells preparation, proper volume of fat cells will be collected from each patient just before each procedure. The stem cells will be injected into each standardized injection point in a superficial manner. The injections points are along the inferior border of cheek and mid-cheek and temple, where will be followed by 10-15 minutes of icing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The therapeutic evaluation of adipose-derived stem cells or fat cells solely on facial rejuvenation
Time Frame: 1,3 and 6 Months Post-Surgery
With the therapeutic evaluation of adipose-derived stem cells and fat cells solely on facial rejuvenation separately, which can reduce wrinkle and augment collagen of face skin. In order to assess the therapeutic effect, the investigators take face photos/make three-dimensional skin CT of face to evaluate the wrinkle and collagen before the therapy. Then take photos of face/ make three-dimensional skin CT of face to evaluate the wrinkle and collagen/ take patient satisfaction questionnaire and clinician assessment in 1 Months post-surgery. Take photos of face/ make three-dimensional skin CT of face/ take patient satisfaction questionnaire and clinician assessment in 3 Months post-surgery. Then take photos of face/ make three-dimensional skin CT of face to evaluate the wrinkle and collagen/ take patient satisfaction questionnaire and clinician assessment in 6 Months post-surgery. The investigators will summarize the therapeutic effect of facial rejuvenation based on the data.
1,3 and 6 Months Post-Surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The therapeutic evaluation of adipose-derived stem cells combined with fat cells on facial rejuvenation
Time Frame: 1,3 and 6 Months Post-Surgery
With the therapeutic evaluation of adipose-derived stem cells combined with fat cells on facial rejuvenation.The investigators take photos of face before the therapy and in 1, 3 and 6 Months Post-Surgery, take three-dimensional skin CT of face to evaluate the wrinkle and collagen and so on at the time points of pre-surgery and in 1, 3 and 6 Months post-surgery. In addition to the therapeutic evaluation, take patient satisfaction questionnaire and clinician assessment in 1, 3 and 6 Months post-surgery. The multiple measurements will be aggregated to arrive at facial rejuvenation. Compare the secondary outcome with primary outcome, then it can summarize the best method of facial rejuvenation.
1,3 and 6 Months Post-Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Medical University

Investigators

  • Principal Investigator: Jin Peisheng, the Affiliated Hospital of the XuZhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

October 2, 2016

First Posted (ESTIMATE)

October 4, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 2, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2016-KL020-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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